Cleared Traditional

K905754 - CAPNOMAC ULTIMA ANESTHESIA MONITOR

K905754 is an FDA 510(k) clearance for CAPNOMAC ULTIMA ANESTHESIA MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K905754 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Jun 1991
Decision
175d
Days
Class 2
Risk

K905754 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA ANESTHESIA MONITOR. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on June 17, 1991 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K905754

510(k) Number K905754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date June 17, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 12
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K905754.
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K896629 · Nellcor, Inc. · Feb 1990
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K896216 · Hewlett-Packard Co. · Jan 1990
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K873194 · Draeger Medical, Inc. · Oct 1987